The main goal of the Pediatric Preclinical Testing Consortium (PPTC) is to develop models that will translate to human clinical practice and effectively prioritize therapies for the treatment of pediatric cancers. An effective Coordinating Center (CC) will be critical to the Consortium?s goals by providing broad organizational, scientific, and analytic expertise to support NCI scientists and the PPTC Research Programs. The CC will also be responsible for developing, implementing, and evaluating a comprehensive PPTC research program, providing leadership in data collection and ongoing program evaluation to ensure that the research program is making optimal progress toward the PPTC mission. Providing the organizational and administrative leadership necessary to enable the Consortium to function efficiently will also be a key function of the CC. RTI?s goal as the proposed CC for the PPTC will be to optimize Consortium progress in generating reliable data to accelerate the development of more effective treatments for children with cancer by achieving the following specific aims: 1. Guide interactions between Consortium members and the pediatric oncology community. Provide the logistical support necessary to run an efficient and productive Consortium through effective teleconferences, webinars, Consortium meetings, and website. Employ these tools to facilitate interactions between PPTC members, pharmaceutical companies, and pediatric oncology advocacy organizations to ensure that promising new therapies are utilized efficiently. 2. Generate reliable predictive data that can be used for prioritization of therapeutic agents in pediatric cancer. Provide efficient and robust procedures for data collection, and statistical analysis of data collected from the Research Programs. 3. Provide the Consortium with a comprehensive, yet flexible set of scientific, statistical, and analytic resources needed to develop an innovative research program for creating a functional Consortium for pediatric preclinical testing. Develop tools to track the status of each potential drug candidate through the preclinical process. Document variables in a Consortium-side data dictionary as one element to build the data management system in REDCap.
Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives. During the 6-month extension period of the PPTC program, RTI will be focused on implementing the processes and tools that was established in year 1, 2, 3, 4 and 5. Our key goals for the 6-month extension will be to: 1. Utilize the developed templates and REDCap database for data collection from each consortium lab as testing of agents is completed 2. Analyze PPTC lab data and provide to the consortium and other stakeholders, such as the pharmaceutical companies. 3. Work with each PI to provide figures and graphs for publications. 4. Provide administrative support with journal submission of abstracts, posters and manuscripts. 5. We will ensure the greatest scientific and clinical impact of testing performed under the Pediatric Preclinical Testing Program (PPTP) and the PPTC by producing two harmonized, standardized databases detailing all experiments, from inception of the PPTP through completion of the extended funding cycle of the PPTC. The first database will contain a record for each mouse at each tumor measurement, while the second database will summarize statistical results for each tested treatment group. The second database will require updating statistical summaries to reflect the most up-to-date statistical methods, and will include summary measures such as event-free-survival difference between treated and controls (T ? C) and ratio of treated to controls (T / C), objective response measure (ORM; e.g., progressive disease, stable disease, complete response), and tumor size area-over-the-curve (AOC). The second database will be readily integrated with resources such as PedcBioPortal. 6. Migration to an automated technical summary report writing template that will be accurate, efficient, easily updated and allowing the PIs to spend more time on data interpretation and recommendations for next steps. 7. Schedule our sixth F2F PPTC SC meeting, coordinate the agenda with NCI and consortium members to address key topics for the PPTC 8. Utilize the website to share data, publications or other information with the scientific community. 9. Conduct site audits of all the Research Program sites. We have already established processes and tools in year 1, 2, 3, 4 and 5 to be able to accomplish all the goals for the 6-month extension and do not anticipate any challenges with implementing these goals.
